A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis
- Conditions
- Autoimmune hepatitis1001965410003816
- Registration Number
- NL-OMON52983
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
1. Probable or definite diagnosis of autoimmune hepatitis according to the
International Autoimmune Hepatitis Study Group criteria (table 2) 9:
• Definite autoimmune hepatitis: >= 7
• Probable autoimmune hepatitis >= 6
2. First presentation of AIH requiring treatment according to the current EASL
guidelines
3. Age >= 18 years
4. Must provide informed consent and agree to comply with the trial protocol
1. Overlap syndrome with PSC or PBC (Paris criteria 29, strong positive AMA,
past liver biopsy or cholangiographic findings compatible with PBC or PSC).2.
Presence of clinical significant hepatic decompensation including:• History of
liver transplantation, current active placement on a liver transplant waiting
list.
• Portal hypertension with complications including: poorly controlled or
diuretic resistant ascites, history of variceal bleeding or related therapeutic
interventions (e.g. variceal banding, transjugular intrahepatic portosystemic
shunts) or hepatic encephalopathy.
• Cirrhosis with complications, including history or presence of: spontaneous
bacterial peritonitis, hepatocellular carcinoma, hepatorenal syndrome
a. N.B. cirrhosis without complications as mentioned above, is not an exclusion
criterion
3. Current treatment with predniso(lo)ne and/or immunosuppressive medication
for an indication other than autoimmune hepatitis4. Current systemic
infection5. Other clinically significant medical conditions that could
interfere with the trial6. If female of childbearing potential: known
pregnancy, or unwilling to practice anticontraceptive measures. 7. History of
noncompliance with medical regimens, or patients who are considered to be
potentially unreliable or unable to participate8. Mental instability or
incompetence, such that the validity of informed consent or compliance with the
trial is uncertain
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the proportion of patients in remission, defined as<br /><br>normalization of serum ALT and IgG levels after 24 weeks of treatment, per<br /><br>treatment group. Secondary endpoints include safety and tolerability of<br /><br>mycophenolate mofetil, time to remission, changes in MELD-score (and its<br /><br>components bilirubine, INR, creatinine), albumin, pseudocholinesterase and<br /><br>N-terminal procollagen-III-peptide, ELF-score and aspects of quality of life.<br /><br>In a sub-study, drug levels will be measured.</p><br>
- Secondary Outcome Measures
Name Time Method